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Electroencephalography (EEG) Predictors of Transcranial Direct Current Stimulation (tDCS) in Obsessive-Compulsive Disorder (OCD)

Primary Purpose

Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-Definition transcranial direct current stimulation
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring transcranial direct current stimulation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age: 18-50 years old;
  • DSM-5 criteria for OCD;
  • Y-BOCS total score > or = 16
  • >or=9 years education

Exclusion Criteria:

  • any additional current psychiatric comorbidity
  • The inability to receive tDCS because of metallic implants, or history of seizures,history of head injury, or history of neurosurgery.
  • Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
  • Any current significant medical condition.
  • serious suicide risk

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tDCS treatment

Arm Description

Cathode transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.

Outcomes

Primary Outcome Measures

Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.
Change in long-interval intracortical inhibition (LICI) and short interval intracortical inhibition (SICI) measured by TMS-EEG
LICI and SICI are TMS-EEG paradigm to assess the extent of cortical inhibition. LICI and SICI will be measured using single and paired TMS pulses applied to the OFC. LICI and SICI will be compared between before and after treatment.
EEG biomarkers as predictors of response to tDCS
LICI and SICI measured by TMS-EEG and resting state EEG will be performed to investigate predictors of response to tDCS in OCD patients.

Secondary Outcome Measures

Change in Obsessive Compulsive Inventory-Revised(OCI-R)
It is an inventory of OCD symptoms with 18 items that are rated on a 5-point Likert scale. Total scores range from 0 to 72, with higher scores indicating more severe OCD symptoms.
Change in The Beck Depression Inventory(BDI)
It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.
Change in The Beck Anxiety Inventory (BAI)
It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.
Change in Pittsburgh sleep quality index(PSQI)
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Change in Side-effect questionnaire
It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.

Full Information

First Posted
June 8, 2020
Last Updated
September 7, 2022
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT04426773
Brief Title
Electroencephalography (EEG) Predictors of Transcranial Direct Current Stimulation (tDCS) in Obsessive-Compulsive Disorder (OCD)
Official Title
Electroencephalography (EEG) Predictors of Response to Transcranial Direct Current Stimulation (tDCS) Treating Obsessive-Compulsive Disorder (OCD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is designed to find Electroencephalogram (EEG) biomarkers to predict transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder.
Detailed Description
The purpose of this study is to explore resting state electroencephalography and transcranial magnetic stimulation and electroencephalography (TMS-EEG) biomarkers that would predict transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder with cathode electrode targeting orbitofrontal cortex (OFC). 30 OCD patients will be recruited to this study and performed once a day, five times a week direct current stimulation treatment for two weeks. The investigators will assess symptom severity before and after two weeks of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale(Y-BOCS), the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory(BDI), Pittsburgh sleep quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator. Resting state electroencephalography and TMS-EEG testing will be conducted before and after tDCS treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS treatment
Arm Type
Experimental
Arm Description
Cathode transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.
Intervention Type
Device
Intervention Name(s)
High-Definition transcranial direct current stimulation
Intervention Description
The tDCS device will deliver a direct current of 1.5mA for 20 minutes. Cathode electrode will be localized in front of the OFC on the Fp2 point according to the EEG international reference. Four anode electrodes will be placed around FP2 (i.e. Fpz, AFz, AF4, AF8).
Primary Outcome Measure Information:
Title
Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Description
It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.
Time Frame
Up to 3 months
Title
Change in long-interval intracortical inhibition (LICI) and short interval intracortical inhibition (SICI) measured by TMS-EEG
Description
LICI and SICI are TMS-EEG paradigm to assess the extent of cortical inhibition. LICI and SICI will be measured using single and paired TMS pulses applied to the OFC. LICI and SICI will be compared between before and after treatment.
Time Frame
Up to 2 weeks
Title
EEG biomarkers as predictors of response to tDCS
Description
LICI and SICI measured by TMS-EEG and resting state EEG will be performed to investigate predictors of response to tDCS in OCD patients.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Change in Obsessive Compulsive Inventory-Revised(OCI-R)
Description
It is an inventory of OCD symptoms with 18 items that are rated on a 5-point Likert scale. Total scores range from 0 to 72, with higher scores indicating more severe OCD symptoms.
Time Frame
Up to 3 months
Title
Change in The Beck Depression Inventory(BDI)
Description
It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.
Time Frame
Up to 3 months
Title
Change in The Beck Anxiety Inventory (BAI)
Description
It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.
Time Frame
Up to 3 months
Title
Change in Pittsburgh sleep quality index(PSQI)
Description
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Time Frame
Up to 3 months
Title
Change in Side-effect questionnaire
Description
It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age: 18-50 years old; DSM-5 criteria for OCD; Y-BOCS total score > or = 16 >or=9 years education Exclusion Criteria: any additional current psychiatric comorbidity The inability to receive tDCS because of metallic implants, or history of seizures,history of head injury, or history of neurosurgery. Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body. Any current significant medical condition. serious suicide risk
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Wang
Phone
+86 34773516
Email
wangzhen@smhc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Wang
Phone
+86 64387250
Email
wangzhen@smhc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Wang, PhD,MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Wang

12. IPD Sharing Statement

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Electroencephalography (EEG) Predictors of Transcranial Direct Current Stimulation (tDCS) in Obsessive-Compulsive Disorder (OCD)

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